Chronic PainNCT06092489
Chronic Rotator Cuff-related Shoulder Pain and Graded Motor Imagery
A study testing graded motor imagery and traditional physiotherapy method in people with Chronic Pain and Shoulder Pain, run by Nuray Alaca at 1 site in Turkey (Türkiye).
Trial summary
Graded motor imagery (GMI) clinical conditions accompanied by many pain and movement problems; It is a treatment, education and rehabilitation process that is based on recently obtained scientific data and current clinical studies, is individually adapted and approaches the individual holistically with a… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Pain, Shoulder Pain
- What is being tested?
- graded motor imagery and traditional physiotherapy method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2023to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years Participants were classified with chronic Chronic Rotator Cuff-related Shoulder Pain if duration was equal or greater than 6 months, as recommended by the International Association for the Study of Pain for research purposes Pain at rest maximum 2 out of 10 on verbal numerical rating scale Pain over the deltoid and/or upper arm region for more than 4 weeks, pain associated with arm movement, and familiar pain reproduced with loading or resisted testing during abduction or external rotation of the arm Patient had to test positive at least 3 out of 5 symptoms-provoking tests: pain during Neer test, Hawkins-Kennedy test, Jobe test, painful arc between 60° and 120°, pain or weakness during external rotation resistance test
Who cannot join
- Bilateral shoulder pain Corticosteroid injections less than 6 weeks prior to the enrolment Participants who were pregnant, Mini Mental State Examination score >24 Clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests or drop arm test) Evidence of adhesive capsulitis (50% or more than 30° loss of passive external rotation) Previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder Symptoms of cervical radiculopathy as primary complaint (tingling, radiating pain in the arm associated with neck complaints) Primary diagnosis of acromioclavicular pathology, shoulder instability Previous medical imaging confirming full-thickness rotator cuff tears or calcifications larger than 5mm Patients with competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy) History of cancer, neurologic, systemic, rheumatic or vascular disorder and use of psychiatric medication Participants performing overhead sport activities for more than 4hours/week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Graded Motor Imagery Therapy Applied in Addition to the Traditional Physiotherapy Program in Chronic Rotator Cuff-related Shoulder Pain.
Graded motor imagery (GMI) clinical conditions accompanied by many pain and movement problems; It is a treatment, education and rehabilitation process that is based on recently obtained scientific data and current clinical studies, is individually adapted and approaches the individual holistically with a biopsychosocial model. Nowadays, it is frequently used in the treatment of some neurological diseases. In addition, these approaches are also used in the treatment of some orthopedic diseases including chronic pain. There are a limited number of studies in which the mentioned approaches are used together in stages, and the stages are mostly used alone. Despite these positive results in favor of GMI, the fact that there is no study using the entire GMI treatment in chronic shoulder pain shows us that a randomized controlled and blinded study with high evidence value should be conducted on this subject. In addition, determining the effect of GMI on changes such as fear of pain, two-point discrimination, and left/right lateralization speed and accuracy task will help fill the literature gaps on this subject. In the light of this information, the question of planned master's thesis study is the effect of GMI treatment applied in addition to traditional physiotherapy in chronic rotator cuff-related shoulder pain on pain level, joint range of motion, functionality, pain-related fear, two-point discrimination and left/right lateralization speed and accuracy compared to only traditional physiotherapy. whether it is superior or not.
- Conditions
- Chronic Pain, Shoulder Pain
- Being tested
- graded motor imagery, traditional physiotherapy method
- Keywords
- chronic pain, shoulder pain, graded motor imagery
- Medical subject headings
- Chronic Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
graded motor imageryOther
The three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes.
traditional physiotherapy methodOther
This protocol included stretching and strengthening exercises. Self-stretching will encapsulate the upper trapezius, pectoralis minor, posterior. Each stretch will consist of 3 repetitions of 30 seconds with a 30 second break between repetitions. Strengthening exercises will be performed using elastic resistance bands (Theraband ®) with 4 levels of resistance (red, green, blue and grey). Sets can be easily changed (without the person reporting muscle fatigue) and progressed with resistance. The therapist will ask about the level of effort required for exercise exercises and whether it would be possible to increase the resistance level. The exercise consists of three sets of 10 repetitions and is completed with 1 rest between them. Strengthening exercises will include prone extension, prone external rotation with abduction, side lying external rotation and serratus anterior strengthening.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physiotherapy Program | Active comparator | Self-stretching will encapsulate the upper trapezius, pectoralis minor, posterior. Each stretch will consist of 3 repetitions of 30 seconds with a 30 second break between repetitions. Strengthening exercises will be performed using elastic resistance bands (Theraband ®) with 4 levels of resistance (red, green, blue and grey). Sets can be easily changed (without the person reporting muscle fatigue) and progressed with resistance. The therapist will ask about the level of effort required for exercise exercises and whether it would be possible to increase the resistance level. The exercise consists of three sets of 10 repetitions and is completed with 1 rest between them. Strengthening exercises will include prone extension, prone external rotation with abduction, side lying external rotation and serratus anterior strengthening . These workouts and workouts are also arranged regularly. After exercise, ice will be applied to the shoulder for 15 minutes. Receives: Other: traditional physiotherapy method |
| Traditional Physiotherapy Program and Graded Motor Imagery Therapy | Experimental | The three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes. Receives: Other: graded motor imagery; Other: traditional physiotherapy method |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Rating Scale (NPRS-11)
he Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain).0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Measured: Change from baseline range of motion at 6th week
The Shoulder Pain and Disability Index
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability between 0 to 100, with a higher value indicating worse condition.
Measured: Change from baseline score of The Shoulder Pain and Disability Index at 6th week
Global Rating of Change scale
Patient satisfaction regarding improvement in shoulder function will be evaluated by the Global Rating of Change scale. All participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly between -3 to +3, with a higher value indicating better condition in this study.
Measured: Change from baseline Global Rating of Change scale at 6th week
Central Sensitization Scale
Central Sensitization Scale, which can be applied in the presence of chronic pain, is used in central sensitization syndromes. It consists of two parts. Part A of the scale includes a Likert scale (0-4 points) that questions health-related symptoms. This section is scored from 0 to 100, with higher numbers being associated with a higher degree of central sensitization. Scores of 40 and above indicate the presence of central sensitization. In section B, it questions whether any of the central sensitization syndromes have been diagnosed before.
Measured: Change from baseline score of Central Sensitization Scale scale at 6th week
Secondary outcomes (7)
Range of motion
Shoulder range of motion is the capability of a joint to go through its complete spectrum of movements.
Measured: Change from baseline range of motion at 6th week]
Pressure Pain Threshold
A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
Measured: Change from baseline Pressure Pain Threshold at 6th week
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.The person may score a total of 52 (Pain Catastrophizing Scale). A high score indicates a high level of catastrophic.
Measured: Change from baseline score of Pain Catastrophizing Scale at 6th week
Fear avoidance belief questionnaire (FABQ)
Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Measured: Change from baseline score of Fear avoidance belief questionnaire at 6th week
The two-point discrimination test
The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception
Measured: Change from baseline two-point discrimination at 6th week
Left/right discrimination (Lateralization)
Right-Left Discrimination will be evaluated with Recognise™ applications (Shoulder and Hand) developed by the "Neuro Orthopedic Institute".
Measured: Change from baseline Left/right discrimination at 6th week
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Motor imagery ability will be assessed with the Kinesthetic and Visual Imagery Questionnaire (KVIQ). The participant gives a score between 1 and 5 for the image he/she imagines: "1 point: no image, 5 points: as clear as the original." This process is repeated for each task and at the end of the survey, kinesthetic imagery score, visual imagery score and total score are calculated.
Measured: Change from baseline Kinesthetic and Visual Imagery Questionnaire at 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start20 Oct 2023
- Primary completion13 Jun 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuray Alaca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nuray Alaca, Acibadem University
- Investigators
- Nuray ALACA, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092489
- Sponsor's protocol ID
- 2023/21-13
- Status last verified
- Jul 2024
- First submitted
- 13 Oct 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sirlan S, Alaca N, Yarar HA, Basci O. Graded motor imagery as an adjunct to comprehensive physiotherapy in chronic rotator cuff-related pain: a single blind randomized controlled trial. BMC Musculoskelet Disord. 2025 Jul 3;26(1):588. doi: 10.1186/s12891-025-08783-w.
PubMed 40611093
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Graded Motor Imagery Therapy Applied in Addition to the Traditional Physiotherapy Program in Chronic Rotator Cuff-related Shoulder Pain.
- ClinicalTrials.gov ID
- NCT06092489
- Acronym / sponsor ID
- 2023/21-13
- Conditions
- Chronic Pain, Shoulder Pain
- Keywords
- chronic pain, shoulder pain, graded motor imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nuray AlacaUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Graded motor imagery (GMI) clinical conditions accompanied by many pain and movement problems; It is a treatment, education and rehabilitation process that is based on recently obtained scientific data and current clinical studies, is individually adapted and approaches the individual holistically with a biopsychosocial model. Nowadays, it is frequently used in the treatment of some neurological diseases. In addition, these approaches are also used in the treatment of some orthopedic diseases including chronic pain. There are a limited number of studies in which the mentioned approaches are used together in stages, and the stages are mostly used alone. Despite these positive results in favor of GMI, the fact that there is no study using the entire GMI treatment in chronic shoulder pain shows us that a randomized controlled and blinded study with high evidence value should be conducted on this subject. In addition, determining the effect of GMI on changes such as fear of pain, two-point discrimination, and left/right lateralization speed and accuracy task will help fill the literature gaps on this subject. In the light of this information, the question of planned master's thesis study is the effect of GMI treatment applied in addition to traditional physiotherapy in chronic rotator cuff-related shoulder pain on pain level, joint range of motion, functionality, pain-related fear, two-point discrimination and left/right lateralization speed and accuracy compared to only traditional physiotherapy. whether it is superior or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Physiotherapy Program | Active comparator | Other: traditional physiotherapy methodSelf-stretching will encapsulate the upper trapezius, pectoralis minor, posterior. Each stretch will consist of 3 repetitions of 30 seconds with a 30 second break between repetitions. Strengthening exercises will be performed using elastic resistance bands (Theraband ®) with 4 levels of resistance (red, green, blue and grey). Sets can be easily changed (without the person reporting muscle fatigue) and progressed with resistance. The therapist will ask about the level of effort required for exercise exercises and whether it would be possible to increase the resistance level. The exercise consists of three sets of 10 repetitions and is completed with 1 rest between them. Strengthening exercises will include prone extension, prone external rotation with abduction, side lying external rotation and serratus anterior strengthening . These workouts and workouts are also arranged regularly. After exercise, ice will be applied to the shoulder for 15 minutes. |
| Traditional Physiotherapy Program and Graded Motor Imagery Therapy | Experimental | Other: graded motor imagery, Other: traditional physiotherapy methodThe three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65 years Participants were classified with chronic Chronic Rotator Cuff-related Shoulder Pain if duration was equal or greater than 6 months, as recommended by the International Association for the Study of Pain for research purposes Pain at rest maximum 2 out of 10 on verbal numerical rating scale Pain over the deltoid and/or upper arm region for more than 4 weeks, pain associated with arm movement, and familiar pain reproduced with loading or resisted testing during abduction or external rotation of the arm Patient had to test positive at least 3 out of 5 symptoms-provoking tests: pain during Neer test, Hawkins-Kennedy test, Jobe test, painful arc between 60° and 120°, pain or weakness during external rotation resistance test
Key exclusion criteria (1 listed)
- Bilateral shoulder pain Corticosteroid injections less than 6 weeks prior to the enrolment Participants who were pregnant, Mini Mental State Examination score >24 Clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests or drop arm test) Evidence of adhesive capsulitis (50% or more than 30° loss of passive external rotation) Previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder Symptoms of cervical radiculopathy as primary complaint (tingling, radiating pain in the arm associated with neck complaints) Primary diagnosis of acromioclavicular pathology, shoulder instability Previous medical imaging confirming full-thickness rotator cuff tears or calcifications larger than 5mm Patients with competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy) History of cancer, neurologic, systemic, rheumatic or vascular disorder and use of psychiatric medication Participants performing overhead sport activities for more than 4hours/week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| graded motor imageryThe three different treatment techniques include left/right discrimination training, explicit motor imagery exercises and mirror therapy. These techniques are delivered sequentially but require a flexible approach from the patient and clinician to move forwards, backward and sideways in the treatment process to suit the individual. With patience, persistence and often lots of hard work, GMI gives new hope for treatment outcomes. | Other | Traditional Physiotherapy Program and Graded Motor Imagery Therapy |
| traditional physiotherapy methodThis protocol included stretching and strengthening exercises. Self-stretching will encapsulate the upper trapezius, pectoralis minor, posterior. Each stretch will consist of 3 repetitions of 30 seconds with a 30 second break between repetitions. Strengthening exercises will be performed using elastic resistance bands (Theraband ®) with 4 levels of resistance (red, green, blue and grey). Sets can be easily changed (without the person reporting muscle fatigue) and progressed with resistance. The therapist will ask about the level of effort required for exercise exercises and whether it would be possible to increase the resistance level. The exercise consists of three sets of 10 repetitions and is completed with 1 rest between them. Strengthening exercises will include prone extension, prone external rotation with abduction, side lying external rotation and serratus anterior strengthening. | Other | Traditional Physiotherapy Program, Traditional Physiotherapy Program and Graded Motor Imagery Therapy |
Primary outcome
The Numerical Rating Scale (NPRS-11)
Time frame: Change from baseline range of motion at 6th week
he Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain).0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
The Shoulder Pain and Disability Index
Time frame: Change from baseline score of The Shoulder Pain and Disability Index at 6th week
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability between 0 to 100, with a higher value indicating worse condition.
Global Rating of Change scale
Time frame: Change from baseline Global Rating of Change scale at 6th week
Patient satisfaction regarding improvement in shoulder function will be evaluated by the Global Rating of Change scale. All participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly between -3 to +3, with a higher value indicating better condition in this study.
Central Sensitization Scale
Time frame: Change from baseline score of Central Sensitization Scale scale at 6th week
Central Sensitization Scale, which can be applied in the presence of chronic pain, is used in central sensitization syndromes. It consists of two parts. Part A of the scale includes a Likert scale (0-4 points) that questions health-related symptoms. This section is scored from 0 to 100, with higher numbers being associated with a higher degree of central sensitization. Scores of 40 and above indicate the presence of central sensitization. In section B, it questions whether any of the central sensitization syndromes have been diagnosed before.
7 secondary outcomes
Range of motion
Time frame: Change from baseline range of motion at 6th week]
Pressure Pain Threshold
Time frame: Change from baseline Pressure Pain Threshold at 6th week
Pain Catastrophizing Scale
Time frame: Change from baseline score of Pain Catastrophizing Scale at 6th week
Fear avoidance belief questionnaire (FABQ)
Time frame: Change from baseline score of Fear avoidance belief questionnaire at 6th week
The two-point discrimination test
Time frame: Change from baseline two-point discrimination at 6th week
Left/right discrimination (Lateralization)
Time frame: Change from baseline Left/right discrimination at 6th week
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Time frame: Change from baseline Kinesthetic and Visual Imagery Questionnaire at 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 40611093Sirlan S, Alaca N, Yarar HA, Basci O. Graded motor imagery as an adjunct to comprehensive physiotherapy in chronic rotator cuff-related pain: a single blind randomized controlled trial. BMC Musculoskelet Disord. 2025 Jul 3;26(1):588. doi: 10.1186/s12891-025-08783-w.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuray ALACA principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing graded motor imagery and traditional physiotherapy method in people with Chronic Pain and Shoulder Pain, run by Nuray Alaca at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numerical Rating Scale (NPRS-11) (time frame: Change from baseline range of motion at 6th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06092489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.